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Status
Ongoing
Phase
III
Objective
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States.
Result: The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. The vaccine regimen was found to be safe.
Last updated January 18, 2023
Prevention Option(s)
HIV Vaccine
Study Design
Placebo-controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid at Months 6 and 12 (different deltoid for each injection).
Mode of Delivery
Intramuscular
Products
Ad26.Mos4.HIV
gp140
ARMs
Experimental
Clade
C/Mosaic
Description
Participants will receive placebo into the deltoid on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Mode of Delivery
Intramuscular
Products
Ad26.Mos4.HIV
ARMs
Placebo Comparator
Official Code
Related Publications
Trial Sponsors
Janssen Vaccines & Prevention B.V.
October 2019
March 2024
Enrollment
3 900
18
Years
60
Years
Population
Men
Sites
Whitman Walker Clinic
Washington, D.C.
United States of America
Gordon E. Crofoot MD
Houston, Texas
United States of America
Helios Salud Sa
Buenos Aires
Argentina
Fundacion Huesped
Buenos Aires
Argentina
Instituto Caici Srl.
Rosario
Argentina
Ospedale San Raffaele
Milano
Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena
Italy
Istituto nazionale malattie infettive 'L. Spallanzani'
Rome
Italy
Hospital Civil Fray Antonio Alcalde
Guadalajara
Mexico
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
Merida
Mexico
Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran
Mexico City
Mexico
Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran
Mexico City
Mexico
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
Callao
Peru
Asociación Civil Selva Amazónica (ACSA)
Iquitos
Peru
Asociacion Civil Impacta Salud y Educacion - Barranco
Lima
Peru
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
Lima
Peru
Asociacion Civil Via Libre
Lima
Peru
Centrum PrEP
Gdansk
Poland
Chmielna Express
Warszawa
Poland
SP ZOZ Wroclawskie Centrum Zdrowia
Wroclaw
Poland
Hosp. Univ. Germans Trias I Pujol
Badalona
Spain
Hosp. Univ. Vall D Hebron
Barcelona
Spain
Hosp. Reina Sofia
Cordoba
Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid
Spain
Hosp. Clinico San Carlos
Madrid
Spain
Hosp. Gral. Univ. Valencia
Valencia
Spain